Plastic Safety for Medical Devices

For years now, plastic has played a vital role in the
medical industry in delivery of safe treatments. Plastic materials have been
used for endless amounts of medical devices and pharmaceutical packaging.
Because plastic tends to ‘leach’ onto materials, it can also be a large
potential source of contamination when they come in contact with other
pharmaceuticals.

Extractables and leachables (E&L) studies have been
researching and evaluating the potential risks of material and drug
interactions. There have been many tests and limitations, as well as uprising
challenges and a new Quality by Designing process (QBD), which has been driving
an ongoing debate. Now, there are going to be implementing significant changes
in the regulations that affect the devices and packaging.

THE NEW QUALITY BY DESIGN PROCESS

The new Quality by Design process was developed by the
International Committee for Harmonization (ICH). They play a crucial role in
the early developmental process. First, they identify Critical Quality
Attribute (CQAs) for a drug product’s safety, efficacy, and quality. After, it
examines and identifies any elements of a product of package that could
potentially present any critical risks. This process imposes the idea that with
care precaution and evaluation, along with a reliable supply chain,
pharmaceutical devices and packaging makers could reduce the amount of related
risks.

WHAT IS E&L TESTING

Plastic materials consist of many substances, either from
the design, or by accident. Accidental substances that mix in with the polymer
matrix can ‘leach’ onto the drug and from there could enter the patient’s body.
During E&L testing, there are several phases that are integrated within
product development. First, substances that are stripped away from devices or
packaging are called ‘extractables’, which are studied further, identified and
evaluated. This provides a lead in the following leachable testing, which can
last three to six years. Leachable testing exposes the pharmaceutical to the
actual product or packaging material for duration of time. This helps
determines whether or not the substance has the capability of leaching onto the
drug.

CHANGE IN E&L TESTING

For over a decade, there have been testing among basic
ingredients used in MEVOPUR concentrates and compounds under a single protocol
that has covered both standards. The protocol was developed because
‘interpretation’ of different testing methods is not always clear. Depending on
the identification of the extractables, biological testing may or may not be
necessary. The standard then recommends what type of tests is necessary
depending on ‘patient contact type’ and ‘contact duration’.